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Tissue Collection Study for Patients With Non-Small Cell Lung Cancer With Resectable Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01450553
Recruitment Status : Unknown
Verified January 2012 by Precision Therapeutics.
Recruitment status was:  Recruiting
First Posted : October 12, 2011
Last Update Posted : January 11, 2012
Information provided by (Responsible Party):
Precision Therapeutics

Brief Summary:

A 15-gene lung signature was created to identify predictive and prognostic biomarkers for Non-Small Cell Lung Cancer (NSCLC) patients. The 15-gene signature was validated using a microarray platform with fresh frozen tumor tissue to place NSCLC patients into high risk and low risk cohorts with significantly different survivals.

Using fresh frozen tissue can be challenging, so this study attempts simplify the process by migrating the 15-gene signature from fresh frozen to two alternative tissue formats: Formalin Fixed Paraffin Embedded (FFPE) and RNAlater.

The gene expressions of the different tissue formats will be compared to see if the fresh frozen tissue results are similar to the alternative tissue formats.

Condition or disease
Non-Small Cell Lung Cancer

Detailed Description:
Patients with early stage NSCLC will be consented prior to surgery so that any excess tissue collected during surgery can be collected in one of the three tissue formats (Fresh Frozen, FFPE, RNAlater) and sent to the Sponsor for testing.

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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Research and Development Study: Tissue Collection From Patients Who Are Undergoing Surgery for Non-Small Cell Lung Cancer
Study Start Date : October 2011

Resource links provided by the National Library of Medicine

Biospecimen Retention:   Samples With DNA

Human tumor tissues will be collected and preserved in three different tissue formats:

  • Fresh Frozen
  • FFPE
  • RNAlater

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Non-Small Cell Lung Cancer patients undergoing surgery for resection of disease from hospital based locations.

Inclusion Criteria:

  • New diagnosis of stage I or II Non-Small Cell Lung Cancer (NSCLC)
  • Must have resectable disease and complete surgical resection planned
  • Histologically or cytologically confirmed adenocarcinoma, squamous or large cell carcinoma NSCLC
  • No prior chemotherapy, biologic/molecular targeted therapy or radiation therapy for this cancer
  • Tumor specimen samples must be collected within 1 hour of surgery
  • Patient must be at least 18 years of age
  • Patient must sign and date an approved study consent form

Exclusion Criteria:

  • Patients with psychiatric or addictive disorders that would preclude obtaining study consent
  • Informed consent obtained the same day as surgery
  • Absence of histological diagnosis of lung cancer
  • Known infectious disease
  • History of chemotherapy, biologic/molecular targeted therapy or radiation therapy for this cancer or any prior cancer or any other non-cancer diseases or illnesses, i.e. rheumatoid arthritis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01450553

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Contact: Hong Ma, MD 1-877-233-7090

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United States, Alabama
Cardio-Thoracic Surgeons, P. C. Recruiting
Birmingham, Alabama, United States
University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States
United States, Florida
Martin Memorial Treasure Coast Surgeons Recruiting
Stuart, Florida, United States
United States, Kentucky
Baptist Hospital East Not yet recruiting
Louisville, Kentucky, United States
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States
United States, Pennsylvania
University of Pittsburgh Medical Center Not yet recruiting
Pittsburgh, Pennsylvania, United States
United States, Tennessee
Centennial Thoraic Surgeons Recruiting
Nashville, Tennessee, United States
Sponsors and Collaborators
Precision Therapeutics
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Responsible Party: Precision Therapeutics Identifier: NCT01450553    
Other Study ID Numbers: RD-110
First Posted: October 12, 2011    Key Record Dates
Last Update Posted: January 11, 2012
Last Verified: January 2012
Keywords provided by Precision Therapeutics:
Tissue Collection
Lung Cancer
Non-Small Cell Lung Cancer
Early Stage Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms